A Randomized, Double-Blind, Multicenter, Parallel-Group Comparative Phase III Study Evaluating the Efficacy and Safety of TAK-816 Compared With ActHIB in Healthy Infants.

Trial Profile

A Randomized, Double-Blind, Multicenter, Parallel-Group Comparative Phase III Study Evaluating the Efficacy and Safety of TAK-816 Compared With ActHIB in Healthy Infants.

Completed
Phase of Trial: Phase III

Latest Information Update: 21 May 2016

At a glance

  • Drugs TAK 816 (Primary) ; Diphtheria tetanus and pertussis vaccine; Hib vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Pertussis; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors Takeda
  • Most Recent Events

    • 22 Jan 2016 According to Takeda media release, the Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application ("NDA") for a conjugate vaccine to prevent infections caused by Haemophilus influenzae type b (Hib) in children aged from 2 months to under 5 years of age.
    • 26 Sep 2013 An NDA was submitted in Japan for TAK-816 for prevention of invasive Hib disease in children based on positive results from this trial, according to a Takeda media release.
    • 01 Feb 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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